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阿达木单抗血清浓度、克罗恩病的临床及内镜疾病活动度:一项拉丁美洲多中心横断面研究

Adalimumab Serum Concentrations, Clinical and Endoscopic Disease Activity in Crohn's Disease: A Cross-Sectional Multicentric Latin American Study.

作者信息

de Souza Letícia Rodrigues, Magro Daniela Oliveira, Teixeira Fábio Vieira, Parra Rogério Serafim, Miranda Eron Fábio, Féres Omar, Saad-Hossne Rogério, Soares Prates Herrerias Giedre, Nisihara Renato Mitsunori, Coy Claudio Saddy Rodrigues, Sassaki Ligia Yukie, Kotze Paulo Gustavo

机构信息

Colorectal Surgery Unit, Pontificia Universidade Católica do Paraná, PUCPR, Curitiba 80910-215, Brazil.

Colorectal Surgery Unit, Universidade Estadual de Campinas, UNICAMP, Campinas 13083-970, Brazil.

出版信息

Pharmaceutics. 2023 Feb 9;15(2):586. doi: 10.3390/pharmaceutics15020586.

DOI:10.3390/pharmaceutics15020586
PMID:36839908
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9967155/
Abstract

Despite some variability in ideal serum Adalimumab (ADA) concentrations, there is increasing evidence that higher concentrations of anti-TNF-α agents can be associated with sustained efficacy, and low or undetectable levels may lead to loss of response. This study aims to correlate serum ADA concentrations with clinical and endoscopic activity in patients with Crohn's disease (CD). A cross-sectional and multicentric study was performed with patients with CD, who used ADA for at least 24 weeks. Patients were allocated into groups according to the presence of clinical or endoscopic disease activity. Serum ADA concentrations were measured and compared between groups. Overall, 89 patients were included. A total of 27 patients had clinically active CD and 62 were in clinical remission. Forty patients had endoscopic disease activity and 49 were in endoscopic remission. The mean serum ADA concentration was 10.2 μg/mL in patients with clinically active CD and 14.3 μg/mL in patients in clinical remission ( = 0.395). The mean serum ADA concentration in patients with endoscopic activity was 11.3 μg/mL as compared to 14.5 μg/mL in those with endoscopic remission ( = 0.566). There was no difference between serum ADA concentrations regarding clinical or endoscopic activity in CD, as compared to patients in remission.

摘要

尽管理想的血清阿达木单抗(ADA)浓度存在一定差异,但越来越多的证据表明,较高浓度的抗TNF-α药物可能与持续疗效相关,而低水平或检测不到的浓度可能导致反应丧失。本研究旨在探讨克罗恩病(CD)患者血清ADA浓度与临床及内镜活动度之间的相关性。对使用ADA至少24周的CD患者进行了一项横断面多中心研究。根据临床或内镜疾病活动情况将患者分组。测量并比较各组之间的血清ADA浓度。共纳入89例患者。其中27例患者临床CD活动,62例处于临床缓解期。40例患者存在内镜疾病活动,49例处于内镜缓解期。临床活动期CD患者的血清ADA平均浓度为10.2μg/mL,临床缓解期患者为14.3μg/mL(P = 0.395)。内镜活动期患者的血清ADA平均浓度为11.3μg/mL,内镜缓解期患者为14.5μg/mL(P = 0.566)。与缓解期患者相比,CD患者临床或内镜活动度在血清ADA浓度方面无差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a32/9967155/1fb1c2b092c1/pharmaceutics-15-00586-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a32/9967155/c141e2d61ca8/pharmaceutics-15-00586-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a32/9967155/1fb1c2b092c1/pharmaceutics-15-00586-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a32/9967155/c141e2d61ca8/pharmaceutics-15-00586-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a32/9967155/1fb1c2b092c1/pharmaceutics-15-00586-g002.jpg

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Gastroenterology. 2022 Jun;162(7):1876-1890. doi: 10.1053/j.gastro.2022.01.044. Epub 2022 Feb 3.
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Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives.炎症性肠病生物制剂的治疗药物监测:未满足的需求和未来展望。
Lancet Gastroenterol Hepatol. 2022 Feb;7(2):171-185. doi: 10.1016/S2468-1253(21)00223-5.
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Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits.
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Clin Chem Lab Med. 2019 Nov 26;57(12):1906-1914. doi: 10.1515/cclm-2019-0202.
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Accuracy of the new rapid test for monitoring adalimumab levels.用于监测阿达木单抗水平的新型快速检测方法的准确性。
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Population-based cohort study on comparative effectiveness and safety of biologics in inflammatory bowel disease.基于人群的炎症性肠病生物制剂比较疗效和安全性队列研究。
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